Navegando por Autor "Bojanowski, Michel W."
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Artigo The Treatment of Brain Arteriovenous Malformation Study (TOBAS): a preliminary inter-and intra-rater agreement study on patient management(Elsevier, 2017-07) Fahed, Robert; Batista, André Lima; Darsaut, Tim E.; Gentric, Jean-Christophe; Ducroux, Célina; Chaalala, Chiraz; Roberge, David; Bojanowski, Michel W.; Weill, Alain; Roy, Daniel; Magro, Elsa; Raymond, JeanObject. – The best management of brain arteriovenous malformation (bAVM) patients remains unknown. Randomized allocation may be more readily accepted when there is uncertainty and disagreement regarding the management of potential participants. In planning for a trial, we aimed to assess variability and agreement among physicians managing bAVM patients. Methods. – A portfolio composed of 35 patients was sent to 47 clinicians of various specialties managing bAVM patients. For each patient, physicians were asked their best management deci sion (surgery/embolization/radiosurgery/conservative), their confidence level, and whether they would include the patientin a randomized trial comparing conservative and curative management. Seven physi cians, who had access to all images of each patient, independently responded twice, to assess inter and intra-rater agreement using kappa statistics. Results. – The inter-rater agreement (30 raters, including 16 neuroradiologists) for best management decision was only “fair” ( [95%CI] = 0.210[0.157; 0.295]). Agreement remained below ‘substantial’( < .6) between physicians of the same specialty, and when no distinctions were made between various treat ments (when responses were dichotomized as conservative versus curative). With access to all images the inter-rater agreement remained fair. The intra-rater agreement reached “substantial” only for the dichotomized decisions. Responding clinicians were willing to include 54.4% of patients (mainly unrup tured bAVMs) in a randomized trial. Conclusion. – There is a lack of agreement among clinicians involved in the management of bAVM patients. In this study a substantial proportion of clinicians were willing to offer randomized allocation of man agement options to a substantial number of patients.Artigo Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial(Trials (London), 2015-11-04) Darsaut, Tim E.; Magro, Elsa; Gentric, Jean-Christophe; Batista, André Lima; Chaalala, Chiraz; Roberge, David; Bojanowski, Michel W.; Weill, Alain; Roy, Daniel; Raymond, JeanBackground: The management of unruptured brain arteriovenous malformation (AVM) patients remains controversial. Furthermore, curative attempts to treat ruptured AVM patients have not been questioned so far, and there is a lack of prospective data on clinical results according to treatment modality. Endovascular treatment is often used aiming to improve the safety or efficacy of surgery or radiation therapy, but benefits have never been documented in a trial. A care trial context is needed to evaluate interventions at the same time they are practised. Methods/Trial design: TOBAS is a pragmatic, prospective, multicenter, randomized, controlled trial and registry which offers a care trial context for brain AVM patients, including surgical resection, radiosurgery or endovascular embolization, alone or combined. The study includes two RCTs and a multimodality prospective registry. The objectives of the proposed study are to assess whether preventive interventions (surgery, embolization, radiation therapy, alone or combined), selected by the local treatment team and performed as locally practiced, randomly allocated and compared with conservative management, in unruptured brain AVM patients eligible for active or conservative management, can improve the proportion of patients having an independent outcome (modified Rankin Scale (mRS) < 3, as assessed by a standardized questionnaire administered by non-masked care personnel) at 10 years. All patients judged ineligible for randomized allocation are to be entered in a multimodal registry. The objective of a nested trial in patients with ruptured or unruptured AVMs to be treated by surgery or radiation therapy, is to assess whether pre-surgical or pre-radiation embolization, randomly allocated and compared with no embolization, can improve the proportion of patients with complete eradication of the AVM, as locally adjudicated, combined with a good clinical outcome (mRS < 3). The study will require up to 2000 patients in approximately 30 centers or more, followed for 10 years. TOBAS is registered at clinicaltrials.gov: NCT02098252 as of 25 March 2014.